In addition, a secondary per-protocol analysis will be performed. The primary outcome measure (the proportion of patients with CD4 + cell counts above 400 cells/mcL) will be analyzed by means of Chi-square or Fisher’s exact test that will be used to analyze all other categorical variables, too. Time to treatment failure will be estimated using Kaplan-Meier product-limit estimates (that will be presented graphically). The log-rank test will be used to assess the difference between the survival curves for each arm, while ANOVA test and Student’s t test will be used for continuous variables unless the variables will not be normally distributed, in which case the Mann-Whitney U tests will be used. Logistic regression analyses (forward stepwise model) will be used to evaluate the relationship between variables and outcome. Comparisons between pairs of groups will bee performed only in the case of a multiple test yielding a statistically significant result.